KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (NCT04165070)
KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- Banner MD Anderson Cancer Center ( Site 0001) — Gilbert, Arizona
- City of Hope ( Site 0014) — Duarte, California
- UCSF Medical Center at Mission Bay ( Site 0007) — San Francisco, California
- Georgetown University ( Site 0036) — Washington D.C., District of Columbia
- University of Kentucky Markey Cancer Center ( Site 0019) — Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland
- Massachusetts General Hospital ( Site 0003) — Boston, Massachusetts
- Dana Farber Cancer Institute ( Site 0002) — Boston, Massachusetts
- Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) — Omaha, Nebraska
- Dartmouth Hitchcock Medical Center ( Site 0016) — Lebanon, New Hampshire
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) — Hackensack, New Jersey
- Laura and Isaac Perlmutter Cancer Center ( Site 0034) — New York, New York
- Sanford Fargo Medical Center ( Site 0039) — Fargo, North Dakota
- Cleveland Clinic Main ( Site 0006) — Cleveland, Ohio
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015) — Columbus, Ohio
- Abramson Cancer Center of the University of Pennsylvania ( Site 0010) — Philadelphia, Pennsylvania
- Sanford Cancer Center ( Site 0038) — Sioux Falls, South Dakota
- The University of Texas MD Anderson Cancer Center ( Site 0009) — Houston, Texas
- Petz Aladar Megyei Oktato Korhaz ( Site 0062) — Győr, Győr-Moson-Sopron
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) — Szolnok, Jász-Nagykun-Szolnok
- Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) — Budapest,
- Soroka Medical Center ( Site 0072) — Beersheba,
- Rambam Health Care Campus-Oncology ( Site 0076) — Haifa,
- Shaare Zedek Medical Center ( Site 0075) — Jerusalem,
- Meir Medical Center ( Site 0071) — Kfar Saba,
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.